Plate, Cranioplasty, Preformed, Non-Alterable
Regulation 882.5330
5510(k)s in 12 months (57 all time)
0recalls in 12 months (11 all time)
11recalls that name a 510(k)
Top companies in GXN
| Company | 510(k)s | Recalls |
|---|---|---|
| Longeviti Neuro Solutions | 8 | 0 |
| Kelyniam Global, Inc. | 2 | 4 |
| Zimmer Biomet, Inc. | 0 | 6 |
| Bioplate, Inc. | 5 | 0 |
| Fin-Ceramica Faenza S.P.A. | 5 | 0 |
| KLS Martin L.P. | 5 | 0 |
| Synthes (Usa) | 5 | 0 |
| Aesculap | 3 | 0 |
| Ikonos Corp. | 2 | 0 |
| Meticuly Co., Ltd. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 22, 2000 | K993990 | LEIBINGER QUIK DISK TITANIUM CLAMP SYSTEM Stryker Instruments | GXN |
| Jul 20, 1999 | K992000 | SYNTHES CRANIAL FLAP TUBE CLAMP Synthes (Usa) | GXN |
| Jul 20, 1999 | K991860 | SYNTHES CRANIAL FLAP TWIST CLAMP Synthes (Usa) | GXN |
| Apr 23, 1999 | K991029 | RAPIDFLAP CRANIAL CLAMP Walter Lorenz Surgical, Inc. | GXN |
| Jul 6, 1998 | K971252 | SEVRAIN CRANIAL CLAMP Ikonos Corp. | GXN |
| May 12, 1998 | K971408 | SEVRAIN CRANIAL CLAMP (SCC-200 SERIES) Ikonos Corp. | GXN |
| Jan 16, 1998 | K972332 | AESCULAP CRANIOFIX TITANIUM CLAMP SYSTEM Aesculap, Inc. | GXN |
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